ConceiveEase (TM)…

Date posted by the FDA

Aug. 27, 2009

Status

Terminated

Filed by

Memphis Fertility Laboratory Inc

Product

ConceiveEase (TM), Fertility Friendly Lubricant, Reproductive Lab, Memphis, TN Intended Use: Personal Lubricant.

Reason

Product was marketed without a 510(k).

Distribution pattern

Nationwide Distribution -- USA, including the state of MA.

Quantity

800 units

Codes and lots

lot: WK0608

Recall started

July 10, 2009

Device type

Lubricant, Personal

Root cause (FDA)

PMA

What the company told customers

The firm notified its sole consignee on 07/10/2009 by telephone and followed by an Urgent Medical Device Recall letter. The letter requested that they examine their inventory and quarantine all products subject to recall and immediately contact Dr. William Kutteh for return instructions. The enclosed response form should be completed and returned. Questions should be directed to Dr. Kutteh at 901-261-2401.

Recall number

Z-1904-2009

What should I do? How serious is a recall? Classes and warnings explained

Source: FDA · Medical device enforcement report, recall number Z-1904-2009. The agency record governs; check it and the company before acting.